Rich Pharmaceuticals has retained IND 2 Results, (I2R) Atlanta Georgia, to serve as its Contact Research Organization (CRO).
I2R will work on protocol development, medical writing, and regulatory consulting for Rich as it plans to move forward with clinical trials in Hodgkin’s Lymphoma (HL). Subsequently, the company intends to have I2R assist in preparing the protocol for submission to the Food and Drug Administration (FDA).
In addition, I2R is assisting the company in amending the Acute Myelocytic Leukemia (AML) protocol in preparation for the Submission Package to a major U.S. clinical site soon-to-be-named, and I2R will also prepare submission packages for the clinical site’s Institutional Review Board (IRB). In cooperation with the clinical site, and subject to the receipt of adequate additional funding, Rich Pharmaceuticals plans to conduct a study for the treatment of AML in refractory patients in Phase I/II trial. AML is a cancer of the myeloid line of blood cells, characterized by the rapid growth of abnormal white blood cells that build up in the bone marrow and interfere with the production of normal blood cells. AML is the most common acute leukemia affecting adults, and its incidence increases with age. Because the incidence increases with age, it is expected that incidence will rise as population ages.
“I2R has a strong track record of success in conducting complicated clinical trials. Its multi-disciplinary team of experienced clinical trial professionals will work with Rich Pharmaceuticals as we move forward with our innovative treatment for lymphoma and leukemia,” said Ben Chang, Rich Pharmaceuticals CEO. “We believe that getting a talented CRO team on board is an important step for our future.”